A process is known from for example EP-A0678574 and WO-A-02/064439 in which an empty vial closed with a puncturable closure made of a thermoplastic elastomer (“TPE”) is provided, pharmaceutical product content is introduced into the vial via a hollow needle passed through the closure, the needle is withdrawn from the vial and closure, and the residual puncture hole is sealed by heating the closure material around the puncture site for example with a laser beam. The closure part may for example be made of a blend of the polymers “Engage” supplied by Dupont-Dow, and “Dynaflex” formerly known as “Kraton” as supplied by Shell but now available from GLS (USA) who supply this blend, and including a dye, e.g. grey, to enhance absorption of laser light so that the elastomer material may be heated using laser light. With this process it is important for the interior of the vial body and at least the part of the closure in contact with the interior of the vial body to be in a sterile condition before the pharmaceutical product content is introduced. For use in this process empty vials with their closure in place may be sterilised by radiation directed at the vials and passing through the vial and closure material, but this radiation sterilising procedure introduces cost and complexity because of the need for a radiation source. Vials, closures and a vial-closure combination suitable for such a process are disclosed in WO-A-04/018317 (based upon GB 0219152.6 filed 16 Aug. 2002) the contents of which are incorporated herein by reference. WO-A-02/064439 discloses vial closures suitable for such a process having a lower infusible portion and a thermoplastic upper part which can be heat sealed e.g. with a focused laser.
The procedure of filling a sterilised container with a sterilised content within a sterilised environment is known in the art, e.g. by the FDA, as an “aseptic” process, i.e. performed under “aseptic” conditions. The term “sterilised” and derivative terms e.g. “sterile” used herein refers to a level of viable micro-organisms at or below a medicinally acceptable level as judged by conventional standards in the field.